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Rx PENTAZOCINE TABLETS
1. What Pentazocine tablets is and what it is used for Pentazocine tablets belong to a group of medicines called analgesics and are used for the relief of moderate to severe pain.
25 MG
2. Before you are given Pentazocine tablets
Package leaflet: Information for the patient Pentazocine 25mg tablets.
Do not take Pentazocine tablets if: • you are allergic (hypersensitive) to Pentazocine, analgesics or to any of the other ingredients of this medicine (listed in section 6) • you suffer from heart problems due to lung disease • you suffer from any brain conditions (including raised pressure in the skull) or head injury • you suffer from asthma, lung disease or have breathing difficulties, especially if you have blue discoloration of the skin (cyanosis) or cough up a lot of phlegm • you suffer from alcoholism or are a heavy drinker • you have porphyria (a group of rare inherited or acquired disorders where there is a problem with the production of haem (used to make haemoglobin in red blood cells) within the body)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. What is in this leaflet 1. What Pentazocine tablets is and what it is used for 2. Before you are given Pentazocine tablets 3. How you will be given Pentazocine tablets 4. Possible side effects 5. How Pentazocine tablets is stored 6. Further Information
Warnings and precautions • taking a pain reliever regularly for a long time may lead to a dependence (addiction) • taking a pain reliever too often or for too long can make headaches develop or worsen. Headaches caused by overuse of medicine should not be treated by increasing the dose.
Talk to your doctor before taking Pentazocine tablets: • if you suffer from phaeochromocytoma (untreated tumour of the adrenal gland) • if you have suffered a recent heart attack due to increases in heart rate and blood pressure • if you suffer from severe kidney or liver problems • if you are elderly, as you may be especially sensitive to the effects of Pentazocine • if you have ever suffered from drug dependency or abuse • if you have a history of or suffer from fits or seizures • if you take other analgesic medicines (See “Other medicines and Pentazocine”) • if you have an underactive thyroid gland (hypothyroidism) • if you have a condition in which the adrenal glands do not produce adequate amounts of steroid hormones (adrenocortical insufficiency) • if you suffer from inflammation (swelling) of the prostate (prostatic hypertrophy) • if you suffer from inflammatory or obstructive bowel disorders • if you suffer from swelling (inflammation) of the gallbladder (cholecystitis) • if you suffer from inflammation of the pancreas (pancreatitis) • if you suffer from unexplained stomach pain • if you are taking medicines used to treat major depressive episodes, known as Monoamine Oxidase Inhibitors (MAOIs) (See “Other medicines and Pentazocine”). Treatment with Pentazocine should only be started 2 weeks after discontinuing treatment with an MAOI
Pentazocine 2 5mg tablets PIL Taj P harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Pe ntazocine Dosage & Rx I nfo | Pentaz ocine Uses, Side E ffects , Pe ntazocine 2 5mg tablets PIL: I ndi cations, Side Effects, Warnings, Pentaz ocine - Drug Infor mation - Taj Phar ma, Pe ntazocine
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Other medicines and Pentazocine tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Medicines which may interact with or be affected by Pentazocine: • Antidepressant medicines known as Monoamine Oxidase Inhibitors (MAOI) in the past 2 weeks - Medicines which make you sleepy including: Phenothiazines such as trifluoperazine, used to treat anxiety, mental disorders, feeling and/or being sick (nausea, vomiting) - Tricyclic antidepressants, used to treat depression such as amitriptyline - Medicines used to improve breathing ability such as doxapram (respiratory stimulants) • Tobacco smoking may decrease the effectiveness of Pentazocine • Strong pain relievers such as diamorphine (heroin), morphine and naloxone • Concomitant use of Pentazocine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Pentazocine together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation
closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Taking Pentazocine tablets with food and drink and alcohol • These tablets should be taken after meals. • Do not drink alcohol while you are taking these tablets. If you drink alcohol whilst taking this medicine the sedative effect may be enhanced. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy • Careful consideration should be given to the use of Pentazocine during pregnancy particularly during the first trimester (first 3 months) or at full term (end of pregnancy). • Regular use during pregnancy may cause withdrawal symptoms in the newborn. Symptoms may include stomach cramps, feeling sick, being sick, restlessness, dizziness, fever and chills. • Clinical monitoring of the newborn, particularly premature infants, is necessary if Pentazocine has been used during labour. Breast-feeding • Pentazocine is passed into breast milk, but in very small amounts. It is advisable to avoid taking Pentazocine whilst breastfeeding. Driving and using machines Pentazocine tablets may cause sedation,
dizziness and occasionally euphoria. Make sure you are not affected before you drive or operate machinery. The medicine can affect your ability to drive as it may make you sleepy or dizzy. • Do not drive while taking this medicine until you know how it affects you. • It is an offence to drive if this medicine affects your ability to drive. • However, you would not be committing an offence if: - The medicine has been prescribed to treat a medical or dental problem and - You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and - It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Pentazocine tablets contain lactose If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How you will be given Pentazocine tablets Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Swallow the tablets with water, after meals. The recommended dose is: • Adults: the usual starting dose is 2 tablets every four hours. Dosage should be within the range of 25-100mg every three to four
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hours. • Children 6-12 years: 25mg every 3 to 4 hours as required. • Children under 6 years: not recommended. • Elderly: your doctor may give you a lower dose. • Patients with liver or kidney problems: your doctor may reduce your dose. If you take more Pentazocine tablets than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
sick (nausea) or being sick (vomiting), nervousness or restlessness, dizziness, fever and chills. • Long-term use of Pentazocine, particularly in high doses, can lead to dependence. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible Side Effects Like all medicines, Pentazocine tablets can cause side effects, although not everybody gets them.
If you forget to take Pentazocine tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
Seek medical advice immediately if you develop the following symptoms: • Allergic reactions (swelling of the face, throat or tongue, difficulty breathing or dizziness) • Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophillia) • Severe blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis) Side effects (most frequent) • Feeling sick (nausea) or being sick (vomiting) • Feeling tired or drowsy • Light-headedness • Dizziness • Sweating
If you stop taking the Pentazocine tablets • It is important that you keep taking Pentazocine for as long as your doctor has told you to. • If you stop taking the tablets you may develop the following withdrawal symptoms: mild stomach cramps, feeling
Other side effects (frequency not known) • High blood pressure (hypertension) or low blood pressure (hypotension) • Slow heartbeat (bradycardia) or fast heartbeat (tachycardia) • Feeling your heartbeat (palpitations) • Poor circulation
Symptoms of overdose include: sleepiness or drowsiness (somnolence), slower or weaker breathing (respiratory depression), low/high blood pressure (hypotension/hypertension), faster heartbeat (tachycardia), seeing or hearing things that are not real (hallucinations), or fits (seizures, convulsions). Poor circulation and unconsciousness or coma may occur in more severe cases.
• Seeing or hearing things that are not real (hallucinations). May occur occasionally • Feeling depressed or discontented (dysphoria) • Visual disturbances • Headache • Feeling disorientated • Mood changes • Nightmares • Difficulty sleeping (insomnia) •Tingling or numbness in the hands or feet (paraesthesia) • Fainting (syncope) • Intense feeling of well-being or elation (euphoria) • Fits (seizures) • Increased pressure in the skull • Confusion • Thought disturbances • Reddening of the face (flushing) • Skin rashes • Skin rashes with the formation of wheals (urticaria) • Skin rash or inflammation (dermatitis) • Severe itching (pruritus) • Constipation • Dry mouth • Pain in lower back or stomach (may be caused by a spasm of the ureter or bile duct) • Depression of the white blood cell count, which is usually reversible • Extremely small pupils of the eyes (miosis) • Breathing more slowly or weakly than usual (respiratory depression) • Muscle tremor • Chills • Low body temperature (hypothermia) • Difficulty passing urine • Changes in the rate or strength of uterine contractions during labour • Lack of sexual desire (decreased libido)
Pentazocine 2 5mg tablets PIL Taj P harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Pe ntazocine Dosage & Rx I nfo | Pentaz ocine Uses, Side E ffects , Pe ntazocine 2 5mg tablets PIL: I ndi cations, Side Effects, Warnings, Pentaz ocine - Drug Infor mation - Taj Phar ma, Pe ntazocine
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Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
5. How Pentazocine tablets is stored Keep out of the sight and reach of children. Store below 25°C in a dry place. Do not use Pentazocine tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment
6. Further information What Pentazocine tablets contains • The active substance (the ingredient that makes the tablets work) is 25mg of pentazocine hydrochloride. • The other ingredients are lactose, magnesium stearate, polyvidone, microcrystalline cellulose (E460), crospovidone. What Pentazocine tablets looks like and contents of the pack Pentazocine tablets are white, circular, biconvex uncoated tablets. Pack sizes are 28 tablets.
Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad 438225, Gujarat, INDIA This leaflet was last revised in November 2019